1. Targeted LV-lead delivery is safe and feasible in a multicenter setting. 2. Image-registration using 2D fluroscopy is non-inferior compared to standard 3D image registration (validation in first five patients). 3. Targeted LV-lead delivery will…
ID
Bron
Verkorte titel
Aandoening
Chronic heart failure with a reduced ejection fraction and dyssynchrony
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility as assessed by the following feasibility criteria:
- Time to perform the placement of the LV lead
- Overall CRT implantation procedure duration
- Number of LV lead repositioning procedures.
Validation of the accuracy of 2D image registration compared to standard 3D image registration (in five patients).
- Procedural efficiency scored by the implanting cardiologist
Achtergrond van het onderzoek
Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the feasibility of the use of real-time guided lead placement using cardiac MRI and fluroscopy in a multicentre setting.
Doel van het onderzoek
1. Targeted LV-lead delivery is safe and feasible in a multicenter setting.
2. Image-registration using 2D fluroscopy is non-inferior compared to standard 3D image registration (validation in first five patients).
3. Targeted LV-lead delivery will increase the proportion of responders, as compared to historic percentage of responders (60-70%).
Onderzoeksopzet
Timepoint 1: Pre-implantation CMR and echocardiography
Timepoint 2: Guided CRT implantation
Onderzoeksproduct en/of interventie
Real-time cardiac Magnetic Resonance-guided lead implantation by CARTBox.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Capacitated adult patients referred for CRT with a class 1 or 2a indication for CRT according to the 2016 European Society of Cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Contraindications for implantation of a CRT device;
- Age <18 years or incapacitated adult;
- Pregnancy or lactation
- Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
- Atrial fibrillation or atrial fibrillation during MRI
- Documented allergic reaction to gadolinium or contrast agent;
- Impossibility to undergo an MRI scan
- Participation in another clinical study that prohibits any procedures other than standard.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8506 |
| CCMO | NL67885.041.19 |
| OMON | NL-OMON49313 |